For the CER template, we are just putting the suggested fields into our work instruction. We had teams get a non-conformance for not using the correct "version" of the template.
Report Format
A suggested report format can be found below.
The contents of the report will vary based on the nature and history of the device under evaluation. If the format does not fit the needs of your device, it is acceptable to create a solution-specific format.
Refer to Appendix A9 of
MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies June 2016 for further information regarding the content of each section.
1. Summary
2. Scope
Device description
Intended use
Definition of claims
Regulatory status
History of changes
3. Background
Justification for search strategy
Standards and guidance
Users and use patterns
Therapeutic alternatives
Known hazards
4. Device under evaluation
Methodology
Equivalence (only when equivalence is claimed)
Manufacturer data
Literature data
Analysis
ER #1: Safety and Risk/Benefit
ER #3: Performance
ER #6: Side effects
5. Conclusions
ER compliance status
Risk/benefit profile
Acceptability
Residual risks
6. Administrative
Update
Dates and signatures